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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Testing Center of Sanitation and Environment Technic Institute - Close Out Letter 1/31/14

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

 

January 31, 2014


Miao Shi-lin
Facility Director
Testing Center of Sanitation and Environment Technic Institute
Soochow University
199 Ren'Ai Road
Suzhou, China 215123


Dear Mr. Shi-lin:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated October 13, 2011. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

 

Sincerely yours,

/S/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
  Radiological Health Chief